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New treatment option for Spinal Cord Injuries
Official title Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury
ClinicalTrials.gov ID: NCT06104735
What this study is testing
- What it's testing
- While physical exercise remains the foundation for any rehabilitation therapy, the team seeks to improve the benefits of exercise by combining it with the concept of "Fire Together, Wire Together" - when brain stimulation is synchronized with spinal cord stimulation, nerve circuits in the spinal cord strengthen - a phenomenon termed "Spinal Cord Associative Plasticity", or SCAP. This project will build on the team's promising preliminary findings.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age between 18-85 years.
- Must have stable prescription medication for 30 days prior to screening
- Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment; abstain from recreational drugs for the...
- Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
You likely can't join if
- Personal or extensive family history of seizures;
- Ventilator dependence or patent tracheostomy site;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of severe head trauma requiring neurosurgery;
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear...
- Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of...
See the full eligibility criteria
- Age between 18-85 years.
- Must have stable prescription medication for 30 days prior to screening
- Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 53 visits)...
- Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
- Personal or extensive family history of seizures;
- Ventilator dependence or patent tracheostomy site;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of severe head trauma requiring neurosurgery;
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines...
- Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional...
- Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in...
- History of significant hearing problems;
- History of bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance;
- Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy; and
- Unsuitable for study participation as determined by study physician.
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.